PROVENT Study Summary

PROVENT is a clinical trial for men diagnosed with prostate cancer who are on active surveillance. It aims to test whether Aspirin and/or Vitamin D3 have the potential to stop low and intermediate risk prostate cancers from developing into high risk cancers.

Active surveillance is increasingly being employed for men with low to intermediate risk prostate cancer but there is a proportion of such men choosing to undergo radical treatment because of anxiety and discomfort over not receiving any form of cancer therapy. It would therefore be advantageous to identify a minimally toxic therapy that could modify a man’s risk of prostate cancer progression while on active surveillance.

If such a therapy was found to reduce cancer progression, it would subsequently reduce the number of men requiring radical therapy because of disease progression and, more men would choose active surveillance as a treatment option rather than opting for radical therapy at the outset.

PROVENT trial at its present stage is referred to as a ‘feasibility study’, designed to find out whether a larger-scale study would be worthwhile in the future. This stage of PROVENT will run for three years in total, and will help us work out whether enough men want to take part, whether the trial is practical, and how quickly we can recruit patients to the trial.

Over recent years there has been a lot of research suggesting that certain commonly used products can prevent cancers from growing and changing. Two such products are Aspirin and Vitamin D3. In this study, men will be selected at random to take either Aspirin or Vitamin D3, both Aspirin and Vitamin D3, or dummy medicines called placebos. Neither the men nor their doctors will know which of the treatments they are taking; this is called a double-blind study.

The study will recruit patients over a period of 12 months. At present we do not know the best length of treatment; however, for this study each patient will be treated for up to 18 months. We are inviting men whose prostate cancer is managed by active surveillance to join the study, and hope to recruit 102 men within 12 months.

If you are suitable for the study, then most of the procedures and tests you will have as part of the study are exactly the same as you would have if you were not taking part, with one or two exceptions